Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
09/19/2008
Trade Name:
Nasacort AQ
Generic Name or Proper Name (*):
triamcinolone
Indications Studied:
Treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older
Label Changes Summary:
Expands pediatric use, or age range, to include patients 2 to 5 years of age Dosing and administration information provided Not recommended for children under 2 years of age An effect on adrenal function in children 2 to 5 years of age cannot be ruled out Pharmacokinetics were evaluated in children 2 to 5 years of age Safety and efficacy were evaluated in one clinical study involving pediatric patients 2 to 5 years old Studies in children >6 months and less than 2 years of age were not performed due to safety concerns since controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Sanofi-Aventis
NNPS:
FALSE'
Therapeutic Category:
Anti-inflammatory, topical
-
-